K934588 is an FDA 510(k) clearance for the CHLORIDE (MF) ASSAY. This device is classified as a Acid, Phosphoric-tungstic (spectrophotometric), Chloride (Class II - Special Controls, product code CHG).
Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E.I., CA). The FDA issued a Cleared decision on February 18, 1994, 148 days after receiving the submission on September 23, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1170.
| 510(k) Number | K934588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 1993 |
| Decision Date | February 18, 1994 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CHG — Acid, Phosphoric-tungstic (spectrophotometric), Chloride |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1170 |